<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2016042827652N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-04</date_registration>
      <primary_sponsor>Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>Effect of ginger powder supplement  on nonalcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of ginger powder supplement on lipid profile, insulin resistance, antioxidant status, inflammatory biomarkers and fatty liver index in owerweight and obese patients with Nonalcoholic fatty liver disease(NAFLD).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22609</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Nonalcoholic Fatty Liver Disease.</hc_freetext>
      <i_freetext>Intervention 1: intervention group:Three ginger capsules 500 mg daily for 12 week. Intervention 2: The placebo group:Three placebo daily for 12 weeks.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roya rafie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Ave., Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3333 3050</telephone>
        <email>rafie.r@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed ahmad hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Ave., Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3333 3050</telephone>
        <email>seyedahmadhosseini@yahoo.com</email>
        <affiliation>Ahvaz Jundishapur University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Men or women aged between 20 to 70 years old who will be diagnosed with NAFLD by ultrasonography scan (with steatosis score equal or greater than 1) and increased levels of liver enzymes (serum levels of alanine aminotransferase and aspartate aminotransferase more than 40 U/L); and Body Mass Index (BMI) of them is greater than 24.9 and lower than 35. Exclusion criteria: Alcohol consumption; Pregnant and lactating women; Any known forms of hepatic or metabolic disease except NAFLD, such as hereditary hemochromatosis, Wilson’s disease, cirosis, diabetes and other metabolic disease; Any history of gastric bypass or intestine surgery; Taking hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine and anti inflammatory drugs; Using nutrition supplements; Hormone Therapy; and Patients with a history of hypothyroidism, Cushing’s syndrome, renal failure, and kidney stones.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group:Three ginger capsules 500 mg daily for 12 week</i_keyword>
      <i_keyword>The placebo group:Three placebo daily for 12 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver steatosis index. Timepoint: Before and after intervention. Method of measurement: Sonography.</prim_outcome>
      <prim_outcome>Insulin Resistance (IR). Timepoint: Before and after intervention. Method of measurement: Based on HOMA IR equation.</prim_outcome>
      <prim_outcome>Liver enzymes (ALT, AST, ALP, GGTٰٰٰ). Timepoint: Before and after intervention. Method of measurement: Microgram/ml - laboratory kit.</prim_outcome>
      <prim_outcome>Tomor necrosis factor alpha (TNF alpha). Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum Total Anti Oxidant Capacity (TAOC). Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>High sensitive C reactive protein. Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Fetuin A. Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Lipid profile (TG, LDL, HDL, Total cholestrol). Timepoint: Before and after intervention. Method of measurement: laboratory kit.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Fasting Blood Sugar (FBS). Timepoint: Before and after intervention. Method of measurement: Colorimetric enzymatic method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Waist to hip ratio. Timepoint: Before and after intervention. Method of measurement: Non-stretchable tape without any pressure.</sec_outcome>
      <sec_outcome>Body Mass Index (BMI). Timepoint: Before and after intervention. Method of measurement: Weight (kilograms) divided by the square of height (meters).</sec_outcome>
      <sec_outcome>Sistolic and diastolic blood pressure. Timepoint: Before and after intervention. Method of measurement: By mercury sphygmomanometer.</sec_outcome>
      <sec_outcome>Fatty liver index. Timepoint: Before and after intervention. Method of measurement: Based on the equation.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-16</approval_date>
        <contact_name>The Ethics Committee of Ahvaz Jundishapur University of Medical Science</contact_name>
        <contact_address>The Ethics Committee, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan blvd. Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
